Statin Therapy to Improve Atherosclerosis in HIV Patients

This study has been completed.

Sponsor:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00965185

First Posted: August 25, 2009

Last Update Posted: October 5, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques less vulnerable, will deter plaque progression, and improve endothelial function. In addition to known cholesterol-lowering and C-reactive protein lowering effects, immunomodulatory effects of statins will lead to a shift from pro-inflammatory monocyte and T cell subsets to less atherogenic subpopulations.

Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal).

For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed.

20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.

Drug: atorvastatin

20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.

Placebo Comparator: placebo

Drug: Placebo

Placebo

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria:

Men and women age 18-60 with previously diagnosed HIV disease

Subclinical coronary artery disease as defined by presence of one or more plaque on coronary CTA without history of cardiac events or cardiac symptoms and no evidence of critical coronary stenosis. Target to background ratio (TBR) as determined by PET of > 1.6.

Stable anti-retroviral (ARV) therapy as defined by no changes in ARV regimen for >6 months

LDL-cholesterol >70 mg/dL and <130 mg/dL

Exclusion criteria:

History of acute coronary syndrome

Contraindication to statin therapy

Current statin use

AST or ALT two times greater than the upper limit of normal or receiving treatment for active liver disease

Renal disease or creatinine >1.5 mg/dL (given the risk of contrast nephropathy during CT angiography of the heart)

Infectious illness within past 3 months

Contraindication to beta-blocker (including moderate to severe asthma or heart block) or nitroglycerin use as these drugs are given as part of the standard cardiac CT protocol. Previous allergic reaction to beta blocker or nitroglycerin.

Patients who report any significant radiation exposure over the course of the year prior to randomization. Significant exposure is defined as:

More than 2 percutaneous coronary interventions (PCI) within 12 months of randomization

More than 2 myocardial perfusion studies within the past 12 months

More than 2 CT angiograms within the past 12 months

Any subjects with history of radiation therapy.

Patients already scheduled or being considered for a procedure or treatment requiring significant radiation exposure (e.g., radiation therapy, PCI, or catheter ablation of arrhythmia) within 12 months of randomization

Pregnancy or breastfeeding

Coronary artery luminal narrowing >70% seen on coronary CTA

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965185